Breast cancer survivors who were at least 6 months post-treatment were randomized into four equal sized groups: no intervention, exercise program alone, a weight loss program alone, or the combination of weight loss and exercise programs. All four groups received two lymphedema compression garments and ongoing lymphedema care paid for by grant funds. All activities were reviewed and conducted in accordance with the University of Pennsylvania's Institutional Review Board. All participants provided written informed consent prior to participating in any study activities.
The WISER Survivor interventions took place in hospital cancer centers, community-based health facilities, and YMCAs. The recruiter, project manager, and principal investigator met with primary hospital stakeholders (cancer center staff, physicians, administrative personnel, lymphedema specialists, nurses, and nutritionists) in order to develop partnerships. It took 6-8 months to solidify partnerships, obtain regulatory approvals, and identify administrative staff prior to mailing recruitment letters from an individual hospital tumor registry. Hospitals received NIH research credits for their institution for each participant enrolled in the study.
The exercise intervention included twice weekly strength training for one year, with the first six weeks supervised by certified fitness professionals. The one year weight loss intervention consisted of weekly small group meetings with a registered dietitian for behavioral counselling for the first six months. During the latter six months, groups met once per month. Participants used a food replacement system for the first five months (Nutrisystem, Inc., Fort Washington, PA) and were weaned onto conventional grocery shopping for the remainder of the year. Participants in the combined intervention group attended both the exercise sessions and the weight loss sessions on the same schedule as described above. Eligibility criteria are outlined in Table 1.